Evaluating MY008211A for treating anemia in PNH patients on anti-C5 therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III clinical trial aims to assess the safety and efficacy of MY008211A in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who continue to experience anemia despite being treated with anti-C5 antibodies. The study is multicenter, single-arm, and open-label, meaning all participants will receive the treatment without a control group. Participants must have a confirmed diagnosis of PNH and have been on a stable regimen of anti-C5 therapy for at least six months, with hemoglobin levels remaining below 100 g/L. The trial will monitor the participants' response to MY008211A through various assessments over the treatment period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male and female participants ≥ 18 years of age and BMI ≥ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size ≥ 10%.
2. Stable regimen of anti-C5 antibody treatment for at least 6 months before treatment, and Hb was still \< 100 g/L.
3. The average hemoglobin level of at least two tests in 4 months before screening \< 100 g/L.
4. The average hemoglobin level of two tests in the central laboratory during screening \< 100 g/L.
5. Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment. If not received previously, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given.

Exclusion Criteria:

1. Patients with reticulocytes \<100x10\^9/L; platelets \<30x10\^9/L; neutrophils \<0.5x10\^9/L.
2. History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.
3. Known or suspected hereditary complement deficiency.
4. Previous bone marrow or hematopoietic stem cell transplantation.
5. Previous splenectomy.
6. A history of malignancy within 5 years before screening, except cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.

Where it's running

• Peking Union Medical College Hospital (PUMCH).
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Wuhan Createrna Science and Technology Co.,Ltd
• Email: lcyxzx@createrna.com
• Phone: 027-68788900

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Oral HS-10542 for paroxysmal nocturnal hemoglobinuria

  This study will test whether the oral drug HS-10542 can reduce hemolysis and raise hemoglobin in adults with PNH, including those not fully helped by C5 inhibitor therapy.

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• Danicopan added to ravulizumab or eculizumab for PNH in Korea

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• Iptacopan use in Korean patients with PNH or C3G

  This post-marketing surveillance study tests how well iptacopan works and how safe it is for Korean adults with PNH or C3G in real-world care.

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• Pozelimab + cemdisiran for adults with PNH whose current treatment isn't working

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• Iptacopan treatment for adults with PNH in China

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  Recruiting at 14 sites Novartis · Hefei, Anhui and 13 other locations · NCT06931691

• Long-term safety and tolerability of HSK39297 for patients with PNH

  This study is testing if continuing treatment with HSK39297 is safe and effective for adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have already used this medication.

  Recruiting Phase 2 Haisco Pharmaceutical Group Co., Ltd. · Nanjing, Jiangsu · NCT06745622

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.